Clinical Associate Submissions Representative, Italy, IQVIA Biotech

Overview

Experteer OverviewIn this role you will lead country-level Site Activation activities for Italy, ensuring regulatory compliance and timely delivery of start-up documents. You will act as a single point of contact for investigative sites, SAMs, and project teams, guiding feasibility and regulatory submissions. You will prepare and review site documents, track approvals, and ensure quality across deliverables. Join a collaborative, compliant team focused on accelerating clinical development for innovative therapies. Responsibilities

Lead complex projects as regulatory/start-up specialist and serve as SPoC for sites and cross-functional teams Ensure SOPs, WIs, quality of deliverables and timelines are followed Prepare and submit submission documents to regulatory bodies Perform feasibility, site ID, startup and activation activities per regulations and SOPs Prepare site documents, review for completeness/accuracy, and track approvals and document release Inform team of completion milestones and provide local expertise during timeline planning Quality control of documents provided by sites Act as SME on specific subjects, mentor junior CSAs, and sponsor-facing interactions Qualifications

BSc in Health Sciences or related field 1 to 3 years' clinical research experience Experience in EUCTR and CTIS submission procedures; feasibility and Italy ICF adaptation beneficial Site contract negotiations with Italian sites beneficial Experience in medical device submissions beneficial Strong knowledge of clinical systems, procedures, and corporate standards Good communication in local language Effective communication, organizational and interpersonal skills Ability to work independently, prioritize tasks, and manage multiple projects Knowledge of GCP/ICH and regulatory guidelines; understanding of regulated clinical trial environment Benefits

incentive plans bonuses health benefits welfare benefits

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